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FDA Approves Latisse For Hypotrichosis Treatment

2008-12-26 12:32

The U.S. Food and Drug Administration (FDA) has approved LATISSE (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE is the first and only FDA-approved, science-based treatment to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.

Available only through a doctor, LATISSE is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. LATISSE users can expect to experience longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain effect, continued treatment with LATISSE is required. If use of LATISSE is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months (average eyelash hair cycle).

LATISSE will be available in the United States by prescription only and is subject to all U.S. guidelines applicable to dispensing a prescription medical product. Based on today's FDA approval, Allergan expects to launch the product nationwide in the first quarter of 2009.

LATISSE solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes. DO NOT APPLY to the lower eyelid. If you are using LUMIGAN or other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE under the close supervision of your doctor.

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LATISSE use may cause darkening of the eyelid skin which may be reversible. Although not reported in clinical studies, LATISSE use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.

It is possible for hair growth to occur in other areas of your skin that LATISSE frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using LATISSE.

The most common side effects after using LATISSE solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE solution may cause other less common side effects which typically occur on the skin close to where LATISSE is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids.

If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your doctor's advice concerning the continued use of LATISSE solution.

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